Ketamine Assisted Psychotherapy for Opioid Use Disorder
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: MORE+KAP, MORE.
- Who it may be relevant to
- Registry conditions: Opioid-use Disorder. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
This pilot clinical trial aims to assess the preliminary efficacy of ketamine as an adjunct for a mindfulness-based intervention for opioid use disorder.
Detailed description
The purpose of this study is to conduct a Stage 1 randomized controlled trial to test a potential optimization of the evidence-based Mindfulness-Oriented Recovery Enhancement (MORE) intervention for opioid use disorder (OUD). Here we will add Ketamine to MORE (MORE+KAP) and test the MORE+KAP intervention versus the standard MORE intervention in a sample of patients receiving medications for OUD (MOUD; e.g, buprenorphine). The primary aim to is evaluate the extent to which MORE+KAP improves OUD treatment relative to MORE. The secondary aim is to identify the psychobiological mediators of MORE+KAP.
Interventions
- Combination product MORE+KAP
Mindfulness-Oriented Recovery Enhancement plus two sessions where 0.5 to 1.5 mg/kg of ketamine are administered intramuscularly - Behavioral MORE
Mindfulness-Oriented Recovery Enhancement
Primary outcome measures
- Drug use [Time frame: From baseline to 3-month follow-up]
Secondary outcome measures (10)
- MOUD use [Time frame: From baseline to 3-month follow-up]
- Emotional Distress [Time frame: From baseline to 3-month follow-up]
- Meaning in life [Time frame: From baseline to 3-month follow-up]
- Opioid craving [Time frame: From baseline to 3-month follow-up]
- Self-transcendence [Time frame: From baseline to 3-month follow-up]
- Affect [Time frame: From baseline to 1-month follow-up]
- Mindfulness [Time frame: From baseline to 3-month follow-up]
- Reappraisal [Time frame: From baseline to 3-month follow-up]
- Savoring [Time frame: From baseline to 3-month follow-up]
- Momentary craving [Time frame: From baseline to 1-month follow-up]
Eligibility criteria
Inclusion criteria
- Diagnosis of Opioid Use Disorder
- Receiving OUD treatment with a buprenorphine formulation
Exclusion criteria
- Previous experience with a mindfulness-based intervention program
- Pregnancy
- Any serious medical, mental, or cognitive issue that prevents successful participation in a mindfulness-based group treatment program
- Prior use of ketamine other than as prescribed by a physician
- Any of the following medical conditions
Blood Vessel Disease Heart Valve Disease Heart Failure Class 2 or Above Heart Disease Pregnancy/Breastfeeding Arteriovenous Malformation History of Intracranial Bleeding or Stroke History of Seizures Hypoxia defined by current need for supplemental oxygen Liver Disease History of allergic reaction to Ketamine Dementia (moderate-severe) History of Psychotic Disorder, Bipolar Disorder, or Personality Disorder Dissociative Identity Disorder
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Double blind
- Primary purpose
- Treatment
Study locations
United States · 1 center
- Center on Mindfulness and Integrative Health Intervention Development — Salt Lake City
Identifiers
NCT: NCT04892251 · IRB_00130630